Specification for Automation Interface

Pub No.:J39931ENIssued: 2020-05-27

Supersedes J39931ENIssued 2018-10-29

Specification for Automation InterfaceVITROS® 4600 Chemistry System

Export authorized under general license GTDA (General Technical Data Available)

IMPORTANTThe information contained herein is based on the experience and knowledge relating to the subject matter gained by Ortho Clinical Diagnostics prior to publication.

Always consult the current Product Instructions for Use (IFU) for complete directions.

Ortho Clinical Diagnostics reserves the right to change this information without notice.

Ortho Clinical Diagnostics 2011-2020.

Table of ContentsSection 1. Introduction ........................................................................................................ 2

Overview .........................................................................................................................................2References and Definitions ............................................................................................................2Document Structure ........................................................................................................................4Assumptions and Dependencies ....................................................................................................4

Section 2. Software Interfaces ............................................................................................ 6Operational Overview .....................................................................................................................6Specifications .................................................................................................................................7

Lab Automation Protocol ..........................................................................................................7Datalink/Session Layer ............................................................................................................7Presentation Layer .................................................................................................................11

Query Analyzer Status ..................................................................................................................24Sample Metering Handshaking ....................................................................................................24Reinitialize Metering .....................................................................................................................27Reinitialize Communications ........................................................................................................29Query Analyzer Inventory/Resources ...........................................................................................29Illegal Commands .........................................................................................................................30Internationalization and Language Support ..................................................................................31Timing Requirements ...................................................................................................................31Lab Automation Communication Scenarios .................................................................................32

Interface Initialization Sequence ............................................................................................32Run Two Samples ..................................................................................................................33Remote Sample Startup Interrupted by Local Sample ...........................................................34Non Fatal Error Condition (Insufficient Inventory) ..................................................................35Non Fatal Error Condition (Unknown Sample ID) ..................................................................36Non Fatal Error Condition (Sample In Position Not Received in Time) ..................................37Fatal Error Condition ..............................................................................................................38Sample Routed Notification ....................................................................................................39Query Analyzer Inventory .......................................................................................................40

Section 3. Hardware Interfaces ......................................................................................... 41Electrical Interfaces ......................................................................................................................41Analyzer Dimensions ....................................................................................................................42Site Specifications ........................................................................................................................43Service Access .............................................................................................................................43

System Heat Rejection and Air Intake Zones ........................................................................44Positional Requirements ...............................................................................................................44System to Track Positioning/Floor Mounts or Anchors .................................................................45

Floor Mounts/Anchors ............................................................................................................46Sample Positioning and Adjustments ...........................................................................................47

Sample Center Device Adjustments: Positioning Responsibilities .........................................47VITROS® 4600 System Metering Proboscis Alignment .........................................................48Point Of Reference (POR) .....................................................................................................49Sample Tube Height: Vertical Dimension for POR ................................................................52

System Dimensions with AT Configuration ..................................................................................53Regulations and Safety Standards ...............................................................................................54

Section 4. Sample Handling .............................................................................................. 55Supported Containers ...................................................................................................................55Containers that are not Supported ...............................................................................................56Sample Quality Recommendations ..............................................................................................56Environmental Issues ...................................................................................................................56

Pub. No.: J39931EN Specification for Automation Interface i2020-05-27 VITROS® 4600 Chemistry System

Section 5. Guidelines for Laboratory Automation System Protocol Tests .................. 57Introduction ...................................................................................................................................57

Purpose ..................................................................................................................................57Audience ................................................................................................................................57Approach ................................................................................................................................57Material Resources ................................................................................................................57Skills Required .......................................................................................................................58

Protocol Tests ...............................................................................................................................58LAS Communication Initialization Test ...................................................................................58Analyzer Status Test ..............................................................................................................59Sampling Complete Test ........................................................................................................60Error Recovery Test ...............................................................................................................61Sample Routed/Host Query Test ...........................................................................................63Request Inventory Test ..........................................................................................................63Request Resources Level Test ..............................................................................................64

Instrument-Based Testing ............................................................................................................64Normal Operations Sample Handling .....................................................................................64

Physical Interfaces .......................................................................................................................65Sample Positioning ................................................................................................................66

Section 6. LAS/LIS Architecture ....................................................................................... 67Methods to Download Test Orders ...............................................................................................67

Single Instrument Download ..................................................................................................67Broadcast Download ..............................................................................................................67Host Query .............................................................................................................................67

Interface Topology ........................................................................................................................67Case 1 ....................................................................................................................................67Case 2 ....................................................................................................................................68Case 3 ....................................................................................................................................69

Section 7. Safety and Precautions ................................................................................... 71Patient Safety Considerations ......................................................................................................71Operator Considerations ..............................................................................................................73Environmental Considerations ......................................................................................................74

ii Specification for Automation Interface Pub. No.: J39931EN VITROS® 4600 Chemistry System 2020-05-27

Revision History

Laboratory Automation Specification

Revision History

Date Section/Page Revision Details

2020-05-27 Front Cover

Revision History

Section 4: Sample Handling Updated the Supported Containers section with following changes:

• Added row for “10.25 diameter with varying lengths” along with its “Fluid Volume”.

• Added row for “Greiner MiniCollect® Complete Z series tubes” along with its “Fluid Volume”.

• Added row for “Sarstedt Microvette® 500 series tubes” along with its “Fluid Volume”.

• Updated “Minimum Fill Requirement” table with addition of a “Notes” column corresponding to each type of “Tube Size Diameter x Length in mm or Type“.

Added following “IMPORTANT” statement in Supported Containers section:

• IMPORTANT: Contact your ortho care representative to verify your system is configured to support the tube types.

• IMPORTANT: Greiner Minicollect® complete Z series and Sarstedt Microvette® 500 series tubes are not approved or cleared for market in the United States. Availability in other markets is subject to regulatory clearance or approval. Please refer to the tube's manufacturer documentation for further information.

2018-10-29 Front Cover

Section 1

Section 3

Section 4

Back Cover

Updated Branding Changes on Front Cover.

Added NOTE in Overview and updated Revision History.

Updated OCD to Ortho for consistency across the manual.

Added details in table for 12-13 mm tube and Updated value from 33 mm to 30 mm.Important added after the table.

Updated the Wycombe Address to Pencoed and Added USA in the Rochester Address.

2011-01-10 N/A Initial release of the specification

Added Publication Date and Superseded Date.

Moved the Revision History to page 1.

Pub. No.: J39931EN Specification for Automation Interface 12020-05-27 VITROS® 4600 Chemistry System

Overview

Section 1. Introduction

Overview

The Automation Interface Guide contains interface specifications to assist Lab Automation manufacturers in adapting Lab Automation systems to the Ortho Clinical Diagnostics VITROS® 4600 Chemistry System (VITROS® 4600 System). This document is intended for Lab Automation Vendors and Ortho Clinical Diagnostics personnel who create interfaces between an automated sample delivery system and the VITROS® 4600 System.

Note: Not all products and systems are available in all countries.

Laboratory Automation System (LAS) refers to the subsystems that support the capability to control an automated track and coordinate sample movement to a processing station, for example, a system. The LAS includes the VITROS® 4600 Chemistry System (VITROS® 4600 System), the Lab Automation Computer (LAC), and the hardware that connects them.

This specification provides an explanation of interfaces between the Lab Automation Vendors and Ortho Clinical Diagnostics. Topics include:

• Information to be transmitted between the Lab Automation System and

the VITROS® 4600 System

• Format of information to be transmitted between the Lab Information System and the system

• Physical relationships between the system and the sample container

• Sample container sizes and aspiration depths

• System footprints and space requirements

• Operator and service access requirements to the system

• Environmental specifications for the system

• System sample throughput specifications

• Electrical interconnects between a Lab Automation System and the system

• Automation interface guidelines for accurate implementation of the Automation Interface Specification

• Summary of considerations for Lab Automation System and Lab Information System architecture

• Summary of Lab Automation Interface risk assessment

References and Definitions

Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

Laboratory Information System (LIS) Guide for the VITROS® 5600 Integrated System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 4600 Chemistry System, J32799EN.

Unpacking and Installlation Instructions for VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: Intact System, J39894

Unpacking and Installation Instructinos for VITROS® 5,1 FS Chemistry System and VITROS® 4600

2 Specification for Automation Interface Pub. No.: J39931EN VITROS® 4600 Chemistry System 2020-05-27

References and Definitions

Chemistry System: Split System, J39895

Installation Instructions for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System: Automation (AT) Accessory, J39893

Installation Instructions for the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: AT Seismic Anchorages, J39896

ISO 8859-1 8-bit single-byte coded graphic character sets -- Part 1: Latin alphabet No. 1

ACK (Acknowledgement Code)A signal passed between computers to signal a receipt of a message.

AnalyzerFor the purpose of this specification, the VITROS® 4600 Chemistry System.

ASCII: American Standard Code for Information InterchangeA system that is used for character encoding.

ASTM: American Society for Testing and MaterialsIn the context of this document, the communication protocols defined by the E-1381 and E-1394 specifications for the communications between clinical laboratory instruments and lab computer systems.

Asynchronous LIS MessagesA feature that enables the system to send unsolicited status updates to the LIS.

CRC: Cyclical Redundancy CheckingAn error checking algorithm used to verify the integrity of an electronic message.

Extended ASCIIA set of codes that extends the basic ASCII set. The basic ASCII set uses 7 bits for each character, giving it a total of 128 unique symbols. The extended ASCII character set uses 8 bits, which gives it an additional 128 characters. Extended ASCII uses the ISO8859-1 implementation to support Western European languages. See ISO 8859-1 8-bit single-byte coded graphic character sets -- Part 1: Latin alphabet No. 1.

GUI: Graphical User InterfaceA computer-user interface based on graphics (icons and pictures and menus) instead of text.

HL7: Health Level SevenA standard message protocol for electronic data exchange in all health care environments including clinical laboratories with automation.

LAC: Lab Automation ComputerA computer used in the LAS to control the track and coordinate sample movement to a processing station.

LAS: Lab Automation SystemThe subsystems that support the capability to control an automated track and coordinate sample movement to a processing station, for example, an Analyzer.

POR: Point of ReferenceA point in space at which the sample tube is placed for external metering.

LIS: Lab Information SystemThe computer system responsible for data management, for example, sample results and patient history.

Sample ProboscisAspiration probe on the system.


Document Structure

Sample CarrierThe device that holds the sample container and interfaces with the transport track to facilitate movement from one location to another.

Sample ContainerThe tube that holds patient samples.

UTF-8Unicode Transformation Format-8 that is an octet (8-bit) lossless encoding of Unicode characters.

Document Structure

The Automation Interface Specification is organized into the following sections:

Section 1. Introduction on page 2Provides general information about the specification

Section 2. Software Interfaces on page 6Describes the software commands and responses exchanged between the system and the lab automation system during sample processing

Section 3. Hardware Interfaces on page 41Describes the physical interfaces between the lab automation system and VITROS® 4600 Chemistry System

Section 4. Sample Handling on page 55Describes requirements for containers used in sample processing with lab automation systems

Section 5. Guidelines for Laboratory Automation System Protocol Tests on page 57Provides guidelines for automation system personnel to use in verifying the correct implementation of an automation interface

Section 6. LAS/LIS Architecture on page 67Discusses considerations applicable in lab automation interfaces in an LIS environment

Section 7. Safety and Precautions on page 71Explains considerations for minimizing risks

Assumptions and Dependencies

• Manual (walk up) samples take priority over samples delivered by the automation system.

• Calibration with fluids delivered by the automation track is not supported. (Controls are not prevented from being delivered by the automation track.)

• Whole blood samples for use on the VITROS® 4600 System require processing from

cups not tubes. These samples should be processed on the VITROS® 4600 System directly.

• The system uses two types of interfaces. The LAS interfaces for sample coordination and the LIS interface for prsystemogram, results, etc.

• The automation system handles movement of all samples not placed manually on the system.

• The automation system stops, captures, positions, and steadies the sample for fluid


Assumptions and Dependencies

aspiration.

• All required information for processing a sample will be supplied to the system. The Lab Automation System for each sample will supply the two items listed below before it is placed in position for metering but after the “SAMPLING COMPLETE” message for the previous sample.

— Sample ID

— Container type (diameter)

• Sample programming for an individual sample must be downloaded prior to its presentation to the system if host query is not enabled.

• When using host query mode, the SAMPLE ROUTED message should be sent to the system as soon as the decision to route the sample to that system has been made by the automation system. This will maximize the time the system has to complete the host query.

• The automation system ensures the integrity of the sample identification for the sample being aspirated.

• If the LAS has not just received a status message or SAMPLE COMPLETE response, the LAS queries the system for its current status before sending a PREPARE TO RUN SAMPLE command.

• The automation system must complete the following steps within the required time period after the SAMPLING COMPLETE message is sent by the system to guarantee maximum system throughput:

— Send the Sample ID information within a PREPARE TO RUN SAMPLE message for the next sample within 100 milliseconds of SAMPLE COMPLETE.

— Place the next sample into the aspiration position.

— Send the SAMPLE IN POSITION message to the system (no more than 6.4 seconds after the PREPARE TO RUN SAMPLE command). The sample must be in position when this message is sent. Failure to meet this 6.3-second time window will result in the sample not being processed by the system.

• The automation system must supply a “setup” mode used with the system's setup and adjustment mode. In this mode, empty tubes are used to adjust the system's metering system to the location where aspiration will be performed.

• The VITROS® 4600 System does not control devices mounted on the automation track.

• The automation system must comply with the site specifications in order for system doors and lids to open and for waste containers to be easily emptied. Refer to Site

Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

• This document does not contain the description of the Graphical User Interface (GUI) but only the functionality of the feature.

• No GUI specifications are detailed in this document.


Operational Overview

• The system software is backward compatible with existing VITROS® LAS communications.

• Communication between the System and the LAC requires an RS-232 compatible serial communications port.

Section 2. Software InterfacesThis section contains the detailed specifications that define the software interface between the VITROS® 4600 System and the LAC.

Operational Overview

Query Analyzer Status

1. The LAC sends a QUERY ANALYZER STATUS command to the system.

2. The system sends a ANALYZER STATUS response to the LAC.

Sample Metering Handshaking

3. The sample tube is loaded onto automation track.

4. The LIS downloads test order to the system.

5. The sample tube is carried to system.

6. The LAC sends a PREPARE TO RUN SAMPLE command to the system. The command contains a sample ID and the container type.

7. The system retrieves a sample program and builds a worklist for the sample.

8. The LAC sends a SAMPLE IN POSITION command to the system, handing over control to the system.

9. The system aspirates fluid from the sample tube.

10. The system sends a SAMPLE COMPLETE response to the LAC, releasing the sample back into the control of the LAC.

Reinitialize Metering

11. The LAC sends a REINITIALIZE METERING command to the system.

12. The system reinitializes any reduced subsystems.

13. The LAC periodically queries the system status until an “ANALYZER IS READY TO SAMPLE” code is received.

Reinitialize Communications

14. The LAC sends a REINITIALIZE COMMUNICATIONS command to the system.

15. If an error occurs and it is recoverable, the system will respond by issuing the READY sequence.

16. The initialization sequence is repeated.


Specifications

Query Analyzer Inventory/Resources

17. The LAC sends a QUERY ANALYZER INVENTORY command to the system.

18. The system retrieves inventory information from the Inventory Manager.

19. The system sends a series of ANALYZER INVENTORY responses to the LAC until all the inventory data has been sent.

20. The LAC sends a QUERY ANALYZER RESOURCES command to the system.

21. The system retrieves resource information from the Inventory Manager.

22. The system sends a QUERY ANALYZER RESOURCES response to the LAC.

Note: Similar functionality is also available with the LIS interface.

Error Handling

The Lab Automation System handles errors encountered during communication. These errors include physical communication errors, framing errors, and logical state transition errors.

Specifications

Lab Automation Protocol

The functions involved in transferring data from the Lab Automation System (system) to the lab computer and the lab computer to the system are divided into these components:

Physical Layer - This is comprised of the actual hardware and software configuration used to communicate between the two systems.

Datalink Layer - This handles the framing and error detection for the sending and receiving of messages.

Session Layer - This handles to establishment of communication, sequence numbering, and error recovery in the sending and receiving of messages.

Presentation Layer - This specifies the content and format of the records to be implemented in this application.

Physical Layer

The system uses 1 start bit.

The system supports 1 or 2 stop bits.

The system supports EVEN, ODD, and NONE parity.

The system supports the following baud rates:

• 9600

• 19200

• 38400

The system uses 8 data bits.

Datalink/Session Layer


Specifications

Message Format

The following special control characters are used:

STX = 0x02

ETX = 0x03

The following forms of message frames are supported:

Byte 1: STX

Byte 2: Message Length

Byte 3: Message Type

Byte 4: Sequence Number

Byte 5 to N-2: Message Body

Byte N-1: CRC

Byte N: ETX

Message lengths are the total number of bytes in the message excluding the STX and ETX.

The following message types are supported:

0x00 Data

0x01 ACK

0x02 NAK

Cyclical Redundancy Checks

The algorithm for computing the Cyclical Redundancy Check (CRC) is the following C code fragment:

unsigned char crc;

crc = 0x84;

for (i = 0; i <= (message_len-1); i++)

{

crc = ((crc >> 1) | (crc << 7)) ^ message_bytes[i];}

Where

message_len is the message length in bytes

message_bytes is the buffer containing the message

Note that this algorithm excludes the STX, ETX and CRC bytes.

Sequence Numbers

The use of sequence numbers in system communications is optional. The LAS selects the use or non-use of sequence numbers.

The system disables the use of sequence numbers if the LAS sets the sequence numbers to 0x00 in the ACK messages that it sends during the initialization sequence.

The system enables the use of sequence numbers if the LAS uses valid, increasing sequence numbers in the ACK messages that it sends during the initialization sequence.


Specifications

Valid sequence numbers are 0 to 255. The number following 255 is 0.

The system maintains two sets of sequence numbers, one for messages originating from the LAS and another for messages originating from the system.

Interface Initialization Sequence

Communication with the system must be restarted whenever a communication link has been broken because the system was turned off or was reset or because an Interface Communication Failure occurred.

The system starts the initialization sequence after a “power on” or “system reset” as soon as the automation control task has initialized.

The system starts the initialization sequence to recover from an interface communication error after receiving a REINITIALIZE COMMUNICATIONS message from the LAS.

The interface initialization sequence begins when the system sends a READY message to the LAS consisting of an STX followed by an ETX.

The system waits up to 1 second for the LAS to respond with an ACK message. If the LAS does not respond, a second READY message is sent.

The initialization sequence is aborted if the LAS does not respond before a 1 second timeout for the second READY.

Note: The LAS responds to the READY message by sending ACK messages no more than 500ms apart.

The system waits up to 1 second for the LAS to respond with a second ACK message. If the LAS does not respond before 1 second, the initialization sequence is aborted.

When the system receives two ACK messages to determine if sequence numbers are used, the system responds to the LAS with its own ACK message. This contains the appropriate sequence number immediately followed by an ANALYZER STATUS message.

See Figure 1: Initialization Sequence.


Specifications

Figure 1: Initialization Sequence

Acknowledgements

After a message is sent, the sender stops transmitting until an acknowledgment is received.

The receiver sends an ACK message to the sender for every message received with a valid CRC and no communication errors.

The receiver sends a NAK message to the sender for every message received with an invalid CRC or a communication error occurred during transmission (example, parity error).

If sequence numbers are enabled, the receiver sets the sequence number of the ACK or NAK message to the sequence number of the message being acknowledged.

CRC checks are not performed on ACK and NAK messages.

Unsolicited ACK and NAK messages are ignored.

Lab Automation System

READY if no response in 1 second

ACK

ACK

ACK

Analyzer Status Message

ACK


ACK


ACK

READY

Sequence Number = A

Sequence Number = A+1


Sequence Number = 0

Sequence Number = 0



Sequence Number = 1

Sequence Number = 1

Initialization Complete

Note: The Query Analyzer Status message is not part of the initialization sequence but is provided to demonstrate sequence numbers following initialization.


Specifications

Interface Communication Failures

Interface communication errors indicate that the Analyzer-to-LAS interface is unreliable. Since the interface is unreliable, communications between the system and the LAS are disabled.

If any of the following conditions occur, the system goes into an error state and reports a condition code:

• The system reports or receives two consecutive NAK messages as a result of two failed send attempts.

• A message acknowledgment is not received within 250ms.

• The last byte received, based on the message length, was not an ETX.

• The interface initialization sequence fails.

• The last byte, based on the message length, was not received within 250ms from the STX.

• The message type field is invalid.

Note: See the REINITIALIZE COMMUNICATION message for recovering from interface communication failures.

Presentation Layer

Message Acknowledged

The Message Acknowledged message is sent to the receiver for every message received with a valid CRC.

The following format is used for the Message Acknowledged message:

byte 1: STX

byte 2: Message Length

byte 3: Message Type = 0x01

byte 4: Sequence Number

byte 5: CRC

byte 6: ETX

Message Not Acknowledged

The Message Not Acknowledged message is sent to the receiver for every message received with an invalid CRC or if a communication error occurred during transmission.

The following format is used for the Message Not Acknowledged message:

byte 1: STX




byte 5: CRC

byte 6: ETX


Specifications

Illegal Command Received

The Illegal Command Received message is sent to the to LAS when an unrecognized command is received or when a logical error occurs, such as an invalid sequence number or when commands are received out of order.

The following format is used for the Illegal Command Received message:

byte 1: STX




byte 5, 6: Message ID = 0xC009

byte 7: Error Type (see the table below)

byte 8, 9: Error Word (see the table below)

byte 10: CRC

byte 11: ETX

Error Type Error Type Description Error Word Contents

0x00Invalid command

A non-existent command was received. An invalid command was received. This could be a message with a Message ID that is not defined, or a Message ID that is not supported by the system. For example, the system does not recognize the ANALYZER STATUS message (0xC007).

MSB = high byte of Message ID receivedLSB = low byte


Specifications

0x01Logical Order Error

A command that violates the logical order of operations was received.A command was sent out of sequence. The system will issue this error under the following conditions:

• A SAMPLE IN POSITION message is sent without a corresponding PREPARE TO RUN SAMPLE message.

• A second PREPARE TO RUN SAMPLE message is sent before the system sends a SAMPLING COMPLETE message.

• A second SAMPLE IN POSITION message is sent before the system sends a SAMPLING COMPLETE message.

• A QUERY ANALYZER INVENTORY message is sent during external sampling.

• A QUERY ANALYZER RESOURCES message is sent during external sampling.

MSB = high byte of Message ID receivedLSB = low byte

0x02Sequence Number Error

A sequence number error was detected. The system issues this error if the use of sequence numbers was enabled during initialization by the LAS, and the system receives a message with a sequence number that does not match the expected sequence number. See REINITIALIZE COMMUNICATIONS for how to recover from this error.

MSB = sequence number expectedLSB = sequence number received



Specifications

Note: LAS commands sent to the system should be spaced at least 100ms apart to allow the system to respond with an ILLEGAL COMMAND message if necessary.


The Query Analyzer Status message is sent by the LAS to request the system report its status. This command is performed before starting a new sample unless a SAMPLING COMPLETE response has just been received.

The following format is used for the Query Analyzer Status message:

byte 1: STX





byte 7: CRC

byte 8: ETX

0x03Invalid Data

Invalid data was discovered in the message. A data field from the previous message contained unexpected data. The following conditions will cause the system to send this error:

• The Container Type in a PREPARE TO RUN SAMPLE message is invalid.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains zero or more than 15 characters.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains invalid UTF-8 characters or insufficient characters (according to the Sample ID Length field).

• The Recovery Type in a REINITIALIZE COMMUNICATIONS message is invalid.

MSB = 0x00LSB:

0x01 = Invalid container type from PREPARE TO RUN SAMPLE

0x02 = Invalid Sample ID length from PREPARE TO RUN SAMPLE or SAMPLE ROUTED

0x03 = Invalid Sample ID data from PREPARE TO RUN SAMPLE or SAMPLE ROUTED

0x04 = Invalid recovery type from REINITIALIZE COMMUNICATIONS



Specifications

Analyzer Status

The Analyzer Status message is sent by the system to indicate its status. This message is sent in response to a QUERY ANALYZER STATUS or as an asynchronous message during the initialization sequence.

The following format is used for the Analyzer Status message:

byte 1: STX





byte 7: Status Code (see table below)

byte 8: CRC

byte 9: ETX

Analyzer Status Codes

Status Codes Status Code Descriptions

0x00Analyzer is ready to Sample

The Analyzer is ready to process a sample. The LAS may issue a PREPARE TO RUN SAMPLE message to the Analyzer.

0x01Analyzer is Busy Performing an External Sample

The Analyzer is processing an external sample (off the automation track). The LAS must wait for a SAMPLING COMPLETE message to be issued by the Analyzer before presenting any new samples to the Analyzer.

0x02Analyzer is Busy Performing an Internal Sample

The Analyzer is processing an internal sample (onboard sample tray). This status is necessary since the use of the Analyzer is lab dependent. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the "Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.

0x03Analyzer is Equilibrating

The Analyzer is in the process of bringing the thermal conditions into proper range for processing samples. This status occurs normally when the Analyzer is initialized or if a thermally controlled component of the Analyzer is opened. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer. It may require 30 to 40 minutes before the Analyzer is ready to sample.


Specifications

0x04Analyzer has a Fatal Error

The Analyzer is inoperable and is not ready to process samples. One or more subsystems have experienced a mechanical malfunction. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator and reroute samples to another Analyzer.

0x05Analyzer is Not Available

This status indicates that the Analyzer is not ready to process samples. It indicates that an operator is performing manual operations such as loading reagents, diagnostics, initializing, or loading an ADD. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.

0x06Failed in the Sample

The Analyzer's metering proboscis has mechanically failed while inside the samplecontainer. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample spill. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to theAnalyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not be moved by the LAS and other samples may be rerouted to another Analyzer until the Analyzer is ready to sample.



Specifications

Prepare To Run Sample

The Prepare to Run Sample message is sent by the LAS to indicate that a sample with the given parameters is being placed for aspiration. This command begins the sampling process.

The following format is used for the Prepare to Run Sample message:

byte 1: STX





byte 7: Reserved (always 0x00)

byte 8: Reserved (always 0x00)

byte 9: Container Type (see table below)

byte 10: Sample ID Length (in bytes)

byte 11 to n: Sample ID (15 characters max)

byte n+1: Reserved (always 0x00)

byte n+2: Reserved (always 0x00)

byte n+3: CRC

byte n+4: ETX

Container Types

Note: The sample tube does not need to be in position at the POR to for the LAS to send the Prepare to Run Sample message.

Note: The contents of reserved fields are ignored.

Note: The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the configured encoding.


0x00 16mm diameter tube

0x01 13mm diameter tube

0x02 10mm diameter tube (10.25 mm)


Specifications

Sample In Position

The Sample in Position message is sent by the LAS to inform the system that the sample it is preparing to run is now in the correct position for sampling to begin.

The following format is used for the Sample In Position message:

byte 1: STX





byte 7: CRC

byte 8: ETX

Sampling Complete

The Sampling Complete message is sent by the system to inform the LAS the metering for the sample is complete.

The following format is used for the Sampling Complete message:

byte 1: STX





byte 7: Metering Status (see table below)



byte n+1: CRC

byte n+2: ETX

Metering Status Codes

In the case of any status that indicates that the sample was not processed, the process of commanding the system to sample should restart by issuing a new PREPARE TO RUN SAMPLE message followed by a SAMPLE IN POSITION message. These commands should be reissued using the same sample ID and parameters as were used for the sample that failed to run.

Note: These status codes are mutually exclusive.

Status Codes Metering Status Descriptions

0x00Sample Aspirated With No Error

The sample was aspirated with no errors. No information is known about sample dispense errors, since the SAMPLING COMPLETE message is sent before any sample is dispensed.


Specifications

0x01No Sample Program For Sample ID

The Analyzer could not find a sample program for the Sample ID that was presented by the LAS. The LAS either routes the sample to another Analyzer with the proper sample program, or coordinates with the LIS to download the sample program and then re-presents the sample to the Analyzer. Consult with the laboratory to determine the desired response to this status.

0x02SAMPLE IN POSITION Not Received In Time

A PREPARE TO RUN SAMPLE message was received but a SAMPLE IN POSITION message was not received in the proper time frame. The SAMPLE IN POSITION message must be issued by the LAS within 6.4 seconds after issuing the PREPARE TO RUN SAMPLE message. The LAS should reissue the PREPARE TO RUN SAMPLE message. This is the only case where a SAMPLING COMPLETE message will be sent prior to a SAMPLE IN POSITION.

0x03Completed With Error

A problem was encountered while aspirating sample from the container. This status can be due to a clot or bubble detected. If Enhanced LIS plus is enabled the LAS can query the LIS for specific error information to decide what the best corrective action is. Since this status indicates that user attention is required for follow-up, consult the laboratory to determine the desired response to this status.

0x04Internal Sample Has Priority

An internal sample is being processed. The LAS should periodically issue a QUERY ANALYZER STATUS message until the Analyzer reports a status of “Analyzer Ready To Sample”. The LAS may then proceed to follow the normal procedure for presenting a sample to the Analyzer by first issuing a PREPARE TO RUN SAMPLE message to the Analyzer. The LAS may also reroute the sample to another Analyzer for processing.

0x05Analyzer Inoperable

The Analyzer is inoperable and is not ready to process samples. One or more subsystems have experience a mechanical malfunction. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator and reroute samples to another Analyzer.

0x06Duplicate Sample ID

Tests are in process for the given sample ID. Duplicate sample IDs are not processed.

0x07Analyzer Not Available

The Analyzer is not ready to process samples. It indicates that an operator is performing manual operations such as loading reagents, diagnostics, initializing, or loading an ADD. The LAS should periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status before presenting any new samples to the Analyzer.



Specifications

Note: The Sample ID should be encoded using UTF-8 or Extended ASCII depending on the configured encoding.


The Reinitialize Metering message is sent by the LAS to request that the system reinitialize any inoperable subsystems on the system. This message also resets the expected sample command on the system allowing the LAS to remove a sample that is in progress.

The following format is used for the Reinitialize Metering message:

byte 1: STX





byte 7: CRC

byte 8: ETX

0x08Metering Failed In the Sample

The Analyzer's metering proboscis has mechanically failed while inside the sample container. The LAS should not attempt to move the sample to prevent the possibility of a broken tube and sample spill. The LAS should attempt to restore the Analyzer to an operational state by issuing a REINITIALIZE METERING message to the Analyzer. The LAS should then periodically issue a QUERY ANALYZER STATUS message to the Analyzer until the status code indicates that the “Analyzer Is Ready To Sample” status. For most cases initialization should take up to two minutes; however there are some situations that could take up to ten minutes. Therefore, it is suggested that, if the LAS does not receive an Analyzer status of “Analyzer Is Ready To Sample” within ten minutes after issuing the REINITIALIZE METERING message, the LAS alert the operator. The current sample should not be moved by the LAS and other samples may be rerouted to another Analyzer until the Analyzer is ready to sample.



Specifications


The Reinitialize Communications message is sent by the LAS to the system to attempt to recover from interface communication failures and sequence number errors.

The following format is used for the Reinitialize Communications message:

byte 1: STX




byte 5, 6: Message ID = 0xC00A

byte 7: Recovery Type (see table below)

byte 8: CRC

byte 9: ETX

Recovery Types

Sample Routed

The LAS send the Sample Routed message to the system when a sample has been routed to the system in order to give the system enough time to perform a query for a sample program if needed.

The following format is used for the Sample Routed message:

byte 1: STX







byte n+1: CRC

byte n+2: ETX


0x00 Restart sequence numbers, using the sequence number byte in the REINITIALIZE COMMUNICATIONS message

0x01 Attempt to recover from an interface communication failure.


Specifications

Query Analyzer Inventory

The Query Analyzer Inventory message is sent by the LAS to request the system report its reagent inventory (carts and packs).

The following format is used for the Query Analyzer Inventory message:

byte 1: STX




byte 5, 6: Message ID = 0xC00C

byte 7: CRC

byte 8: ETX

Analyzer Inventory

The system sends a sequence of Analyzer Inventory messages in response to a QUERY ANALYZER INVENTORY request from the LAS.

The following format is used for the Analyzer Inventory message:

byte 1: STX




byte 5, 6: Message ID = 0xC00D

byte 7: Last message; 0x01 indicates last message in response, otherwise 0x00

byte 8: Number of assays in message (max of 10 per message)

byte 9 to 6n+8: One repetition per assay

byte 1, 2: Analyte Code

byte 3, 4: Available test count

byte 5: Current Calibration

bit 1: Serum current

bit 2: CSF current

bit 3: Urine current

bit 4: Whole Blood current

bit 5: Plasma current

bit 6: Amnio current

bit 7: Cord Blood current

bit 8: Reserved value


Specifications

byte 6: Calibrated Status

bit 1: Serum calibrated

bit 2: CSF calibrated

bit 3: Urine calibrated

bit 4: Whole Blood calibrated

bit 5: Plasma calibrated

bit 6: Amnio calibrated

bit 7: Cord Blood calibrated

bit 8: Reserved value

byte 6n+9: CRC

byte 6n+10: ETX

Query Analyzer Resources

The Query Analyzer Resources message is sent by the LAS to request the system report its resources (bulk fluids, tips, cuvettes, waste, etc.).

The following format is used for the Query Analyzer Resources message:

byte 1: STX




byte 5, 6: Message ID = 0xC00E

byte 7: CRC

byte 8: ETX

Analyzer Resources

The Analyzer Resources message is sent by the system to the LAS in response to the QUERY ANALYZER RESOURCES command.

Note: Bytes 13, 14, 15, 16, 25 and 27 are sent by the system but ignored by the LAS.

The following format is used for the Analyzer Resources message:

byte 1: STX




byte 5, 6: Message ID = 0xC00F

byte 7, 8: ERF Level

byte 9, 10: IWF Level

byte 11, 12: Reserved, set to 0x0000 (possible SWF)

byte 13, 14: Signal Reagent Level



byte 15, 16: UWR volume in mL

byte 17, 18: VersaTip supply count

byte 19, 20: MicroTip supply count

byte 21, 22: Cuvette supply count

byte 23, 24: Available MicroSlide waste count

byte 25: Available MicroImmunoassay waste percent full

byte 26: Available reagent metering tip waste percent full

byte 27: Available liquid waste percent full

byte 28: Number of diluents

byte 29 to 4n+28: One repetition per diluent

byte 1, 2: Diluent Code

byte 3, 4: Available count or volume in mL.

byte 4n+29: CRC

byte 4n+30: ETX

Note: If the VersaTip hopper sensor is blocked, an accurate count of VersaTips cannot be determined, only that the number of tips available is greater than 300. This condition is encoded with 0xFFFF and the count is considered an infinite supply of tips.


When the LAS sends a QUERY ANALYZER STATUS, the system responds with an ANALYZER STATUS message containing the appropriate status code based on the current state of the system.

Note: The LAS may query the system for status at any time, and should do so before any requests to process samples.


A three-message handshake between the LAS and system to meter a sample consists of the following messages in the order listed:

1. PREPARE TO RUN SAMPLE - passes the control of a sample to the system and provides the sample ID and container type information.

2. SAMPLE IN POSITION - informs the system that the sample is at the POR and ready for metering.

3. SAMPLING COMPLETE - passes the control of the sample back to the LAS and provides metering status.

See Figure 2: Sample Metering Handshake.



Figure 2: Sample Metering Handshake

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Sample Position Not Received In Time” if no SAMPLE IN POSITION message is received within 6.4 seconds of receiving a PREPARE TO RUN SAMPLE.

Note: In the worst case, the SAMPLE IN POSITION message needs to be received about 6.4 seconds after receiving a PREPARE TO RUN SAMPLE message.

Note: In addition, the LAS needs to send a PREPARE TO RUN SAMPLE message for the next sample within 100ms after receiving a SAMPLING COMPLETE message in order to maintain throughput. Failure to meet this timing may result in a skip cycle.

Note: The only time a SAMPLING COMPLETE message is sent before a SAMPLE IN POSITION message will be if the SAMPLE IN POSITION is not received in time.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “No Sample Program For Sample ID” if no sample program could be found for the sample ID in the PREPARE TO RUN SAMPLE message.



ACK

ASM - Ready to SampleACK

Prepare to Run SampleACK

ACK

Sample in Position

ACK


ASM - External in Progress

ACK

Sampling CompleteACK

Note: ASM = Analyzer Status Message



The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Completed With Error” if an error occurred that would prevent running one or more tests.

Note: This situation only applies to aspirate errors, which are any error that occur while the proboscis is over the sample container.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Internal Sample Has Priority” if an internal sample is being metered when the SAMPLE IN POSITION message is received.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Analyzer Inoperable” if one or more subsystems are in a reduced state when the SAMPLE IN POSITION message is received.

Note: The LAS may attempt to recover from this status by issuing a REINITIALIZE METERING command.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Duplicate Sample ID” if there are tests in process for the sample ID in the PREPARE TO RUN SAMPLE message.

Note: The duplicate sample will not be processed.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Analyzer Not Available” if the system is unable to process samples when the SAMPLE IN POSITION message is received.

Note: This situation occurs during initialization, equilibration, ADD loading, diagnostics mode or when some Options & Configuration screens are displayed.

The system sends a SAMPLING COMPLETE message to the LAS with the metering status code set to “Metering Failed In The Sample” if a mechanical error with the metering system occurred when the proboscis was inside the sample container.

It is assumed that a sample program has been downloaded before the PREPARE TO RUN SAMPLE command. However, if the system is configured for host query, a mechanism needs to be in place to initiate a host query independent of the PREPARE TO RUN SAMPLE. The SAMPLE ROUTED message facilitates this. A SAMPLE ROUTED message is sent to the system as soon as the LAS has routed a sample to it in order to maximize the time available to perform a host query.

The system attempts to send a host query when it receives a SAMPLE ROUTED message for the sample ID contained in the message.

See Figure 3: Sample Routed Notification.



Figure 3: Sample Routed Notification


The system attempts to reinitialize any inoperable subsystems when it receives a REINITIALIZE METERING message from the LAS.

Note: The LAS issues a REINITIALIZE METERING message when an ANALYZER STATUS has an inoperable status or SAMPLING COMPLETE indicates sampling failed due to an inoperable system or metering failed in the sample.

A REINITIALIZE METERING message resets the Sample Metering Handshake so the next expected message is PREPARE TO RUN SAMPLE.

A REINITIALIZES METERING message aborts any further sample aspirations from the interface where the message is received.

Note: The sample processing acts as if a mechanical sample aspiration error occurred. The aborted reps are coded “ME” and reps that have already aspirated will continue to process normally.



ACK

Analyzer Status MessageACK


ACK

Sample in Position

ACK

Sample in Bypass

Sample in Bypass

ACK

Sampling Complete

ACK

Note: Each Sample in Bypass message initiates a host query to the LIS.



See Figure 4: Reinitialize Metering.

Figure 4: Reinitialize Metering



ACK

Analyzer Status Message (ASM)ACK


ACK

Sample in Position


ACK

ACK


ACK

Sampling Complete (Failed in Sample or Analyzer Inoperable)

ASM - Analyzer Initializing

ACK

Query Analyzer StatusACK

ASM - Analyzer is Ready

ACK





If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Reset Sequence Number,” the system restarts the expected sequence numbers using the sequence number in the REINITIALIZE COMMUNICATIONS message.

Note: The LAS may issue a REINITIALIZE COMMUNICATIONS message after receiving an ILLEGAL COMMAND RECEIVED message with “Sequence Number Error” error type.

If the system receives a REINITIALIZE COMMUNICATIONS message with a recovery of “Recover From Communication Failure,” the system starts the Interface Initialization Sequence.

Query Analyzer Inventory/Resources

If the system receives a QUERY ANALYZER INVENTORY message, the system responds with an ANALYZER INVENTORY message(s) containing the current assay reagent inventory.

Note: The content of the system inventory matches what is shown on the View by Assay screen. within Reagent Management. This reports the worst case for each assay across all fluids and reagents. Uncalibrated reagents will not be counted since they cannot be used.

If the system receives a QUERY ANALYZER RESOURCES message, the system responds with an ANALYZER RESOURCES message containing the current onboard resource levels.

See Figure 5: Query Analyzer Inventory/Resources.


Illegal Commands

Figure 5: Query Analyzer Inventory/Resources

Illegal Commands

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Invalid Command” if any of the following conditions are met:

• The Message ID is not recognized.

• The Message ID belongs to a message that only the system should send (for example, ANALYZER STATUS).

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Sequence Number Error” if all the following conditions are met:

• Sequence numbers are enabled.

• The sequence number of an incoming message does not match the expected sequence number.


Query Analyzer InventoryACKAnalyzer Inventory(last message = 0x00)

ACK

ACK

ACKQuery Analyzer Resources

Analyzer ResourcesACK

Analyzer Inventory(last message = 0x00)

Analyzer Inventory(last message = 0x01)

ACK


Internationalization and Language Support

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Logical Order Error” if any of the following conditions are met:

• A SAMPLE IN POSITION message is sent without a corresponding PREPARE TO RUN SAMPLE.

• A second PREPARE TO RUN SAMPLE message is sent before the system sends a SAMPLING COMPLETE message.

• A second SAMPLE IN POSITION message is sent before the system sends a SAMPLING COMPLETE message.

• A QUERY ANALYZER INVENTORY message is sent during external sampling.

• A QUERY ANALYZER RESOURCES message is sent during external sampling.

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS with the error type set to “Invalid Data” if any of the following conditions are met:

• The container type in a PREPARE TO RUN SAMPLE message is invalid.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains zero or more than 15 characters.

• The Sample ID in a PREPARE TO RUN SAMPLE or a SAMPLE ROUTED message contains invalid UTF-8 characters or insufficient characters (according to the sample id length).

• The recovery type in a REINITIALIZE COMMUNICATIONS message is invalid.

Internationalization and Language Support

The system supports the following configurations for Sample ID character encoding:

• UTF-8 (Unicode)

• Extended ASCII (Refer to ISO 8859-1.)

Timing Requirements

The automation system must complete the following steps within the required time period after the SAMPLING COMPLETE message is sent by the system to guarantee system throughput. Failure to meet this timing will result in decreased system throughput.

• Time from SAMPLING COMPLETE to PREPARE TO RUN SAMPLE - 100 milliseconds.

• Time from SAMPLING COMPLETE to SAMPLE IN POSITION- 6.4 seconds (6.5 seconds after PREPARE TO RUN SAMPLE).

All ACK and NAK messages must be sent within 250ms of the received command/response.

ACK messages sent by the LAS during the initialization sequence should be separated by no more than 500ms.

LAS commands sent to the system must be spaced at least 100ms apart to allow the illegal command response. This is to allow the system time to respond with an ILLEGAL COMMAND RECEIVED message if required.

The last byte of a message, based on the message length, must be received within 250ms from receipt of the STX.


Lab Automation Communication Scenarios


Interface Initialization Sequence

Figure 6: Interface Initialization Sequence


READY if no response in 1 second

ACK

ACK

ACK if no response in 0.5 second


ACK


ACK


ACK

READY

Sequence Number = A



Sequence Number = 0

Sequence Number = 0



Sequence Number = 1

Sequence Number = 1

ACKSequence Number = A+2

Initialization Complete

Note: The Query Analyzer Status message is not part of the initialization sequence but is provided to demonstrate sequence numbers following initialization.



Run Two Samples

Figure 7: Run Two Samples




ACK

ACKSample in Position

ACK

ACK

ACK

ACK

Sample in Position

ACK


ASM - Remote in Progress

ACK


ASM - Remote in Progress


ASM - Manual Operation

Prepare to Run Sample

ACK

Sampling Complete


ACK

ACK

Sampling Complete

ACK

ACK


ASM - Ready to Sample




Remote Sample Startup Interrupted by Local Sample

Figure 8: Remote Sample Startup Interrupted by Local Sample




ACK


ACK

ACK

ACK

ACK

Sample in PositionACK


ASM - Remote in ProgressACK






ACKSampling Complete


ACK

ACK

Sampling Complete (did not sample - Manual had priority

ACK

ACK


ASM - Ready to Sample




Non Fatal Error Condition (Insufficient Inventory)

Note: In the case of multiple tests per sample and only some of the tests have insufficient inventory, the tests which have inventory will be posted to the Lab Automation.

Figure 9: Non Fatal Error Condition (Insufficient Inventory)




ACK


ACK

ACK

Sampling Complete - Completed with Error


Sampling Complete


ACK




Non Fatal Error Condition (Unknown Sample ID)

Figure 10: Non Fatal Error Condition (Unknown Sample ID)




ACK


ACK

ACK

Sampling Complete - Unknown Sample ID


Sampling Complete


ACK




Non Fatal Error Condition (Sample In Position Not Received in Time)

Figure 11: Non Fatal Error Condition (Sample In Position Not Received In Time)




ACK

ACK

ACK

Sampling Complete - Sample in Position Not Rec’d in Time


Sampling Complete


ACK


ACK



Fatal Error Condition

Note: If the system still reports a fatal condition after reinitialization, an operator must be called to check the system. The module and error number reported to the LIS will contain more information about the error.

Figure 12: Fatal Error Condition



Analyzer Status Message (ASM)ACK

ACK


ACK

Sampling Complete - Failed in Sample or Analyzer Inoperable


ASM - Analyzer Initializing


ACK

Initialize Analyzer

ACK

ACK


ASM - Analyzer is Ready

ACK


ACK




Sample Routed Notification

Note: Each Sample Routed message initiates a host query to the LIS.

Figure 13: Sample Routed Notification


Sample Routed (SID1)ACK

ACK


ACK

Sampling Complete

Sample Routed (SID2)

ACK

ACK

Prepare to Run Sample (SID2)

ACK

Sample in Position

ACKSampling Complete

Prepare to Run Sample (SID1)



Query Analyzer Inventory

Figure 14: Query Analyzer Inventory


Query Analyzer InventoryACK

ACK

ACKQuery Analyzer Resources

Analyzer Resources

ACK

ACK

Analyzer Inventory(Last message = 0x00)


ACK



Electrical Interfaces

Section 3. Hardware Interfaces

Note: In this section, line drawings reflect the VITROS®5,1 FS Chemistry System; however, the

VITROS® 4600 Chemistry System has the same dimensions and mechanical interface as

the VITROS® 5,1 FS Chemistry System.

Electrical Interfaces

Analyzer to Laboratory Information System (LIS)

Refer to the Laboratory Information System (LIS) Guide for VITROS® 5600 Integrated System, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 4600 Chemistry System, J32799.

Analyzer to Lab Automation System

Full RS232 LAS communication interface. The following pins are used (system side):

3 - transmitted data (TxD)

2 - receive data (RxD)

5 - circuit common

The interface has a communication port to the Lab Automation Computer.

Communication parameters:

1 start bit

8 data bits

1 or 2 stop bits

EVEN, ODD or no parity

9600, 19200 or 38400 baud rate.

The system end is a 9-pin DTE male.

No Hardware or Software flow control.

Cable Requirements for LAS port

Data Rate (bps) Length meters (ft.) 9,600 15m (50 ft.) max.

Shielded 22AWG wire

Electrical Interface at Sample

The frame section of the Lab Automation System, which supports the sample must be connected to safety ground. The lab automation system and Analyzer must not be physically connected.


Analyzer Dimensions

Analyzer Dimensions

This section describes the overall size of the VITROS® 4600 System.

Figure 15: Analyzer Dimensions

Reference Description

A 233.7 cm (92 in)

B 83.8 cm (33 in)

C 132.1 cm (52 in)

D 205.7 cm (81in)

Weight 612.4 kg (1350 lb)


Site Specifications

Site Specifications

The VITROS® 4600 Chemistry System site specifications are described completely in Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897 explain:

• Electrical Power Requirements

• System Environmental Specifications

• Requirements at the Customer Site

• Specifications for the VITROS® 4600 System and Printer

• Specifications for the optional Heat Rejection Plenum

Deviations from site specifications should be reviewed with a Ortho Clinical Diagnostics Field Service Representative.

It is recommended that the floor be level within one inch over 10 feet.

Service Access

The system requires service access from all four sides of the machine. Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897 indicates the appropriate clearances. Access to the machine depends on the track configuration and must be determined by both Ortho and the automation vendor. Some general guidelines are:

• Track and supports should be configured to allow access to rear panel quarter-turn fasteners.

• Spacing between the track and system should allow the removal of the rear panel covers by unfastening the quarter-turns, tipping the covers away from the system, lifting the rear panels several inches, and moving the panels to the side of the system.

Figure 16: Service Access


Positional Requirements

System Heat Rejection and Air Intake Zones

The system contains air intake ports and exhaust ports. The location of these ports are shown in Figure 17. These ports must not be blocked.

The thermal characteristics of the system are explained in Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.

Figure 17: Air Intake and Exhaust Ports

Positional Requirements

This section describes the relative position between system and the sample container. It is assumed that the Lab Automation System will be able to capture and hold the sample container to allow direct aspiration by the system. The following assumptions apply relative to the interface between the two systems.

• The system will be located relative to the automation track through a supplied clamping mechanism mounted to the floor.

• The automation track can be configured to meet the system requirements for sample tube height. See Sample Tube Height: Vertical Dimension for POR on page 52

• The system provides a limited amount of adjustment of the sample metering proboscis in the “X”, “Y”, and “Z” directions of the sample travel path. Refer to Figure 18.


System to Track Positioning/Floor Mounts or Anchors

Figure 18: Positional Requirements - Back of System (With Cabinetry)


Ortho Clinical Diagnostics provides two methods of locating and positioning the system to the floor in order to maintain alignment relative to the automation system. These floor mounts also allow service personnel to disengage the system for service and reposition the system relative to the automation system.The ability to repeat the exact position of system relative to the original POR depends on the following

The ability to restore the system to the exact position relative to the original POR depends on the following factors:

• The anchors have been installed correctly. Reference the Installation Instructions for

the VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: AT Seismic Anchorages, J39896.

• The engagement of the system with the anchors is not so aggressive to cause a shift in anchor positions relative to the floor.

• The automation track is rigidly mounted so there is no relative motion between the system and the track. It is highly recommended to check the alignments of the system to the track position if it has been moved (disengaged from anchors) for some reason.

VITROS® 4600 System Metering Proboscis Alignment on page 48



Floor Mounts/Anchors

Two types of floor mounts can be used to position the system relative to the automation system. Which type of mount to use depends on the site install requirements.

Standard Floor mounts / Anchors

Standard Anchors are included in the AT Accessory and do not need to be ordered separately

Figure 19: Standard Floor Mounts.

Seismic Floor Mounts /Anchors Catalog # 6802245

These are intended for use where seismic events are of concern. The design of these floor mounts have been submitted for approval by California Office of Statewide Health Planning and Development (OSHPD) regulations on earthquake brackets (ref OAS-MIS-PH3001 and OPA-0627). These anchors are ordered in addition to the AT Accessory.

Figure 20: Seismic Mounts


Sample Positioning and Adjustments


Relative to sample positioning, the following rules apply:

• Maximum fluid aspiration depth is 3.86 inches (98mm) from top of the sample tube. See Supported Containers on page 55 for fill requirements.

• For Aspiration, all sample tubes regardless of size are to be centered about the same vertical axis.

• Ortho provides a software adjustment for set-up at the customer site to align proboscis with the track. The range of adjustment will be 50mm (2.0 inch) in “X” direction of metering probe travel. Once this value is set, repeatability of positioning in “X” direction should be +/- .028 inch (0.7 mm).

Sample Center Device Adjustments: Positioning Responsibilities

The following table indicates the alignment adjustment responsibilities for the sample position to the aspiration probe for each degree of freedom in a three-dimensional space.

Adjustment Responsibility

Y Direction Automation Supplier

X and Z Directions Ortho Fine positionAutomation supplier for Coarse position to suggested Point Of Reference (POR)

Rotation about X axis Automation Supplier

Rotation about Y axis Automation Supplier

Rotation about Z axis (Not required)



Figure 21: Sample Position

VITROS® 4600 System Metering Proboscis Alignment

When the system and the sample tube grasping/centering device on the track are properly aligned, the proboscis with disposable tip should travel to a depth of 98 mm in a 13mm diameter sample tube, without touching the inside wall. This alignment is primarily supported by the system proboscis adjustment (horizontal and perpendicular to sample travel) and sample position adjustment along the track length.

Figure 22: System Proboscis

The Lab Automation System vendor has complete responsibility for the positioning the sample tube. However, the adjustments indicated in Sample Center Device Adjustments: Positioning Responsibilities on page 47 facilitates alignment between the system and LAS.

Dimensions shown are in mm.



Point Of Reference (POR)

Point Of Reference//Point in space is the intersection of the XY plane and the axis of the sample tube once positioned for system metering. It is used as the common reference for the system and Automation system. The design of the VITROS® 4600 System accommodates the Clinical and Laboratory Standards Institute (CLSI) standards.

Figure 23: Point of Reference



Figure 24: Point of Reference - Back of System



Figure 25: Point of Reference - Side View



Sample Tube Height: Vertical Dimension for POR

Position of sample tube shown below is based on 100mm tube lengths. Dimensions are given to the bottom of the tube in alignment with the CLSI standards. Metering operations assume 100 mm tube height.

Figure 26: Sample Tube Position


System Dimensions with AT Configuration

System Dimensions with AT Configuration

This section describes the overall size of the VITROS® 4600 Chemistry System with AT (Automation) Accessories. See Figure 27 and Figure 28.

Figure 27: VITROS® 4600 System with Seismic Anchors - Front View

Figure 28: VITROS® 4600 System with Seismic Anchors - Side View

Figure 29 displays the optional heat rejection plenum that diverts hear from the system directly into the laboratory’s ventilation system. If a customer requires a heat rejection plenum, Ortho and the automation vendor should review any spatial conflicts. See Site Specifications for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System, J39897.


Regulations and Safety Standards

Figure 29: VITROS® 4600 System with Heat Rejection Plenum

Regulations and Safety Standards

The VITROS® 4600 Chemistry System is designed to meet Regulatory and Safety requirements for a worldwide market.


Supported Containers

Section 4. Sample HandlingSupported Containers

All but the 10.25 diameter container measurements assume that the track is set up for the system to aspirate from 100mm tube lengths.

Minimum Fill Requirement

IMPORTANT: THE USE OF MICRO COLLECTION SAMPLE TUBES (ALSO COMMONLY REFERRED TO AS PEDIATRIC TUBES OR CAPILLARY TUBES) ON LABORATORY AUTOMATION SYSTEMS CAN ONLY OCCUR IF THOSE SAMPLE TUBES MEET BOTH THE SPECIFICATIONS FOR USE OF THE LABORATORY AUTOMATION SYSTEM AND THE ANALYZERS INTENDED TO PROCESS THEM.

IMPORTANT: CONTACT YOUR ORTHO CARE REPRESENTATIVE TO VERIFY YOUR SYSTEM IS CONFIGURED TO SUPPORT THE TUBE TYPES.

Tube Size Diameter x Length in mm or Type

Fluid Volume µL Notes

16 x 100 200 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 00.

16 x 75 200 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 00.

12-13 x 100 200 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 01.

12-13 x 75 200 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 01.

10.25 diameter with varying lengths

The tube must have a minimum fill of 30 mm below the rim plus test volume.

The “Prepare To Run” message should identify the con-tainer as type 0 x 02.

Prior to V3.6 software, the tube must be supported so that the top rim of the tube is positioned at the same lo-cation as a 100 mm tube.

With V3.6 software, system adjustment is required.

Greiner MiniCollect® Complete Z series tubes (representative geometry, Greiner Item #450549)

230 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 02.

V3.6 software or greater is required.

Sarstedt Microvette®

500 series tubes (representative geometry, Sarstedt Order # 20.1343) for75 mm carrier (representative geometry, Sarstedt Order # 55.525)

80 µL plus test volume The “Prepare To Run” message should identify the con-tainer as type 0 x 02.

V3.6 software or greater is required.


Containers that are not Supported

IMPORTANT: GREINER MINICOLLECT® COMPLETE Z SERIES AND SARSTEDT MICROVETTE® 500 SERIES TUBES ARE NOT APPROVED OR CLEARED FOR MARKET IN THE UNITED STATES. AVAILABILITY IN OTHER MARKETS IS SUBJECT TO REGULATORY CLEARANCE OR APPROVAL. PLEASE REFER TO THE TUBE'S MANUFACTURER DOCUMENTATION FOR FURTHER INFORMATION.

Containers that are not Supported

Cups are not supported by remote sampling but they can be used for local (on-system) sampling.

Sample Quality Recommendations

The sample automation system should allow for primary tube sampling.

If secondary aliquot tubes are used, they should minimize:

• Sample contamination with microorganisms

• Out-gassing of volatile sample constituents for any volatile assays

• Long term sample degradation

Environmental Issues

• Sample tubes should remain uncapped for the minimum amount of time to maintain sample quality.

• Sample caps should be replaced on the sample container shortly after testing has been completed. This will help to ensure sample quality for any follow-up testing that may be required.

• For installations in brightly lighted areas, opaque or amber shielding of the tubes or opaque or amber tubes will help maintain sample quality.

• Installations with high particulate counts should have dust baffles positioned to protect open sample containers.


Introduction

Section 5. Guidelines for Laboratory Automation System Protocol Tests

Introduction

Purpose

These guidelines assist automation system personnel in verifying that the Automation Interface Specification between a Lab Automation System (LAS) and VITROS® 4600 System has been implemented correctly. The guidelines suggested in this section do not represent a complete validation tool for the Lab Automation System supplier. Rather, they outline major areas of concern for basic, fundamental operation. Lab Automation System suppliers should consider using and reviewing these guidelines at their sites before the first customer delivery.

The objective of these guidelines is make sure that the fluid is aspirated correctly; the guidelines do not test assay performance.

Audience

These guidelines are primarily designed as a communications tool for both the Lab Automation Supplier and Ortho Clinical Diagnostics personnel to ensure that the appropriate interfaces have been tested.

Approach

These guidelines address the actual system to Lab Automation interface by reviewing both the software and physical interfaces.The software interfaces include the system to LAS connection as well as the system to LIS connection. The physical interface includes topics such as track height and system aspirate depth.

Material Resources

The following materials and equipment are required in order to verify implementation of the Automation Interface Specification:

• VITROS® 4600 System

• Laboratory Automation System to be evaluated with the VITROS® 4600 System (includes physical hardware, LAS, and LIS)

• Disposables items including:

— Tips

— Tubes

— Reservoirs

— Reagents

— Fluids (water, in most cases)

• V-Docs, the on-system documentation

• Automation interface emulation software


Protocol Tests

Skills Required

The guidelines are designed for personnel who have a basic understanding of the VITROS® 4600 System and the Lab Automation System to be tested. Suggested personnel involved in the evaluation of the interface between the VITROS® 4600 System and the automation system should include:

• Customer Technical Service Lab Automation Representative (Ortho)

• Technical Specialist(s) representing the Lab Automation System supplier

• Technical Specialist(s) representing the Lab Information System supplier

Protocol Tests

The LAS protocol tests described in this section require that the automation system's LAS port be connected to the system, including a passive line-monitoring device. Message time stamping should be less than 100ms resolution. All message sequences should follow the timing constraints defined in Timing Requirements. Communication sequences should be tested with the VITROS® 4600 System with Automation enabled; however, a simulator tool may be used to verify the formatting and logical ordering of messages. When these guidelines refer to “Analyzer,” a simulator tool may be substituted and/or required.

Each step in the protocol test is numbered and the action and expected result are provided. Use the Actual Result column to record the outcome of the step.

LAS Communication Initialization Test

The LAS Communication Initialization test confirms compliance with the Analyzer/LAS communications protocol, including:

• Initialize communications sequence

• Message acknowledged

• Message not acknowledged

• Sequence numbers

• Query Analyzer status

• Analyzer status

• Reinitialize communications

Refer to Interface Initialization Sequence on page 32.

Item Action Expected Result Actual Result

1 Send the READY message from the system to the LAS.

The LAS begins the initialization sequence.

2 From the LAS, send the REINIT COMMUNICATIONS message.

The system responds and sends a READY message, beginning the initialization sequence.


Protocol Tests

Analyzer Status Test

The Analyzer Status test verifies compliance with the system/LAS communications protocol, specifically the system status that is sent by the system to the LAS. The following Analyzer Status messages are verified:

• Analyzer is ready to sample

• Analyzer is busy processing an external sample

• Analyzer is busy processing an internal sample

• Analyzer is equilibrating

• Analyzer has a fatal error, check LIS error messages (inoperable)

• Analyzer is not available (diagnostics, for example) (

• Analyzer has failed in the sample

3 • From the LAS, send a QUERY ANALYZER STATUS command.

• Then, from the system, send an ANALYZER STATUS response.

The system acknowledges the QUERY ANALYZER STATUS command. The LAS acknowledges the ANALYZER STATUS response.

4 • From the automation system, send a QUERY ANALYZER STATUS command.

• Then, from the system, send an ANALYZER STATUS response with an incorrect CRC value. (This step may require a simulator.)

The system acknowledges the QUERY ANALYZER STATUS command. The LAS sends a NAK message in response to the incorrect CRC in the ANALYZER STATUS response.

5 If the LAS uses sequence numbers, repeat steps 1 through 4 using each sequence number. Enable sequence numbers as described in the section Sequence Numbers on page 8. Test sequence number wrap around condition.

Control flow and status messages are the same as in steps 1 through 4. Ensure that the sequence numbers are incrementing in each command/ response pair.



Protocol Tests

Refer to Query Analyzer Inventory on page 40.

Sampling Complete Test

The Sampling Complete test verifies the SAMPLING COMPLETE status that is sent by the system to the LAS for each sample ID. The following SAMPLING COMPLETE metering statuses are verified:

• Sample aspirated as expected

• No sample program for sample ID

• SAMPLE IN POSITION message not received in time

• Completed with error, check error conditions and Analyzer status

• Internal sample has priority

• Analyzer inoperable, query system status

• Duplicate sample ID

• Analyzer not available

• Metering failed in sample.


1 • From the LAS, send a QUERY ANALYZER STATUS command.

• Then, from the system, send an ANALYZER STATUS response.

The system acknowledges the QUERY ANALYZER STATUS command. The LAS acknowledges the ANALYZER STATUS response.

2 Repeat step 1, sending back all possible Analyzer Status codes to the QUERY ANALYZER STATUS command. (This step may need a simulator.)

The LAS accurately interprets and takes appropriate action for each ANALYZER STATUS response. Refer to Analyzer Status Codes in Analyzer Status on page 15.


Protocol Tests

Refer to Sample Metering Handshaking on page 24.

Error Recovery Test

The Error Recovery test verifies the ability of the automation interface to recover after an error occurs. The following error conditions are verified:

• Communications Error

• Loss of Communications

• Incorrect Sample ID

• Invalid Container Type

• Invalid Recovery Type

Refer to Illegal Commands on page 30.


1 • From the LAS, send a PREPARE TO RUN SAMPLE and a SAMPLE IN POSITION command to the system.

• From the system, send back a SAMPLE COMPLETE message with a status of “Sample Aspirated As Expected.”

The system acknowledges the PREPARE TO RUN SAMPLE and SAMPLE IN POSITION messages. Ensure the Sample Complete status is interpreted correctly by the automation system and that the proper action is taken with the sample.Refer to Metering Status Codes in Sampling Complete on page 18.

2 Repeat step 1, sending back all possible SAMPLE COMPLETE status values. (This step may need a simulator.)

The automation system accurately interprets and takes appropriate action for each SAMPLE COMPLETE response.


1 • From the LAS, send a command to the system containing an invalid CRC value.

• Send the same message again with a valid CRC value.

• The system does not acknowledge the first command.

• The system acknowledges the second command.


Protocol Tests

2 • From the LAS, send a command to the system containing an invalid CRC value.

• Resend the command again with the invalid CRC value.

On receiving the second incorrect CRC, the system stops accepting any new commands until a REINITIALIZECOMMUNICATIONS command is sent.

3 Send a REINITIALIZE COMMUNICATION message to recover from the interface communications error generated in step 2.

Normal operation resumes.

4 From the LAS, send an undefined message to the system. The system sends an ILLEGAL COMMAND RECEIVED message to the LAS.

The LAS interprets the ILLEGAL COMMAND RECEIVED message.

5 From the LAS, send a PREPARE TO RUN SAMPLE command to the system with an invalid container type.

The system sends an ILLEGAL COMMAND RECEIVED message to the LAS. The LAS interprets the ILLEGAL COMMAND RECEIVED message.

6 From the LAS, send a PREPARE TO RUN SAMPLE command to the system with a non-printable character in the sample ID.


7 Reinitialize communications with the system with sequence numbers enabled. From the LAS, send a command with an invalid sequence number.


8 From the LAS, send a REINITIALIZE COMMUNICATIONS command to the system to reset the sequence number.

Normal communication resumes.



Protocol Tests

Sample Routed/Host Query Test

The Sample Routed/Host Query test validates the ability to initiate a host query from the system through the automation interface. The following condition is tested using the SAMPLE ROUTED message.

Refer to Sample Metering Handshaking on page 24.

Request Inventory Test

The Request Inventory test validates the ability to request and receive inventory from the system through the automation interface.

Refer to Query Analyzer Inventory/Resources on page 29.

9 From the LAS send a REINITIALIZE COMMUNICATIONS command to the system with a recovery type of 0xFF


10 From the LAS, send a PREPARE TO RUN SAMPLE and a SAMPLE IN POSITION command to the system. From the system, send a SAMPLE COMPLETE message containing a different sample ID than the one in the PREPARE TO RUN SAMPLE command.

The system acknowledges the PREPARE TO RUN SAMPLE message and the SAMPLE IN POSITION message. The automation system recognizes the different sample ID in the SAMPLE COMPLETE message as an error.


1 Send the SAMPLE ROUTED message from the LAS specifying a sample ID.

The LIS receives a host query from the system for the sample ID specified in the SAMPLE ROUTED message.


1 Send the QUERY ANALYZER INVENTORY message from the LAS.

The automation system interprets the ANALYZER INVENTORY response(s) correctly. If multiple data packets are required to receive the inventory information, the data packets are handled correctly.



Instrument-Based Testing

Request Resources Level Test

The Request Resources Level test validates the ability to request and receive resource levels from the system through the automation interface.

Refer to Query Analyzer Inventory/Resources on page 29.

Instrument-Based Testing

Normal Operations Sample Handling

Normal Operations Sample Handling tests the ability of the LAS to communicate with the system and process a sample using all sample control commands in sequence.

Refer to Query Analyzer Status on page 24 and Sample Metering Handshaking on page 24.


1 Send the QUERY ANALYZER RESOURCES message from the LAS.

The automation systeminterprets the ANALYZERRESOURCES responsecorrectly.


1 While monitoring the LAS communications, send the QUERY ANALYZER STATUS message from the LAS.

The LAS receives and correctly interprets the ANALYZER STATUS message. The automation system should not present a sample to the system unless the status is “Analyzer is Ready to Sample.”

2 While monitoring the LAS communications, send the PREPARE TO RUN SAMPLE command to the system.

The LAS receives the proper responses. If the time between PREPARE TO RUN SAMPLE and SAMPLE IN POSITION exceeds the time specified in Timing Requirements on page 31, a status of “Sample In Position Not Received In Time” is posted.

3 Wait for the system to send the SAMPLE COMPLETE response.

The LAS acknowledges the SAMPLE COMPLETE message. The sample ID matches the one in the PREPARE TO RUN SAMPLE command.


Physical Interfaces

Physical Interfaces

This section reviews the physical interfaces between the Lab Automation System and the VITROS® 4600 Chemistry System. Before beginning this evaluation, set up and adjust the system to track interface following the installation procedure found in the Unpacking and Installlation Instructions for VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: Intact System, J39894 or Unpacking and Installation Instructinos for VITROS® 5,1 FS Chemistry System and VITROS® 4600 Chemistry System: Split System, J39895. Also refer to the Installation Instructions for the VITROS® 5,1 FS Chemistry System and the VITROS® 4600 Chemistry System: Automation (AT) Accessory, J39893. Use double-sided tape to place the floor mounts temporarily.

4 From the LAS, process two consecutive samples with a delay of 1 second between the SAMPLE COMPLETE message from the system for the first sample and the PREPARE TO RUN SAMPLE message from the LAS for the second sample.

The system processes the samples. The system throughput is reduced and there is a delay between processing the first and second sample.

5 From the LAS, process two consecutive samples. Send the PREPARE TO RUN SAMPLE message for the second sample 100ms after receiving the SAMPLE COMPLETE message for the first sample.

The system processes the samples. The system throughput is not reduced; there is no delay between processing the first and second sample.

6 Load a sample in the STAT lane of the system and start sampling. Then attempt to process a sample from the LAS.

The system processes the sample from the STAT lane of the system and sends a SAMPLE COMPLETE message to the LAS with a metering status of “Internal sample has priority.”



Physical Interfaces

Sample Positioning

The Sample Positioning test evaluates the ability of the Lab Automation System to properly position a sample tube for fluid aspirated by the system. Refer to Sample Positioning and Adjustments on page 47.


1 Verify that the Lab Automation System allows the sample positioning device to be adjusted along the length of the track and fixed into position.

The automation system sample positioning device must be adjustable along the length of the track to ensure alignment of the sample with the system proboscis travel.

2 Measure the height to the top of the longest sample tube from the floor when properly positioned for sample aspiration by the sample positioning device.

When sample metering is adjusted to the tallest tube height 100mm, aspirate depth is 98 mm maximum from that point.

3 • In normal operating sample handling mode, fill 13mm sample tubes with just enough fluid for 1 test per sample.

• Place sample tubes on the track and route them to the system for processing.

• Watch the sampling probe as it drops into the tube to aspirate fluid.

• Record any observations of the proboscis or tip contacting the side of the sample tube.

When the system is rigidly mounted and properly adjusted, there should be no contact between the sampling probe and the sample tube.


Methods to Download Test Orders

Section 6. LAS/LIS Architecture

Methods to Download Test Orders

Several methods are used to send test orders to the instrument.

• Single Instrument Download

• Broadcast Download

• Host Query

Single Instrument Download

Single instrument download is one of the simplest ordering schemes; test orders are sent to a single instrument where the sample is destined to arrive. The major drawback to this approach is that the destination of a sample must be known in advance. If the sample is routed to a different instrument, no order for the sample would be available on the alternate instrument.

Broadcast Download

Broadcast downloading sends orders for samples to all instruments in the system, eliminating the problem with single instrument downloads. With broadcast downloads, orders are always available wherever a sample may arrive. When results are uploaded from the instrument for a sample that has run, the orders can be deleted from the remaining instruments. VITROS instruments can be configured to automatically delete orders after a specified interval if this functionality is not available in the LIS/LAS. If test orders are not deleted from other systems, tests may be run more than once if the sample is routed again to another system.

Host Query

In host query mode, the instrument requests test orders when the sample arrives. This eliminates the need for order cleanup and the risk of running unnecessary tests. It also reduces the bandwidth load on the network especially in configurations with many instruments. Due to the near-real-time nature of this approach, the turnaround time from test request to order download is important. If the order does not arrive before the sample for the system can't process the sample. For the same reason, this method is less tolerant of network disruption than the other approaches. Depending on the workflow in the lab (for example a reference lab where most orders are sent down at the beginning of a shift), with broadcast download you can run the system with no LIS connectivity while previously downloaded orders are used.

Interface Topology

With a Laboratory Automation System added to the system, the interfaces between the LIS, LAS, and instruments may have several configurations.

Case 1

The LIS communicates directly to all instruments, both on-track and off-track.

The LAS must notify the LIS of any samples it creates so the orders for those samples can be available to the instruments on the system. If the link between the LIS and LAS is not present, then only samples downloaded from the LIS can be run without manual programming on-track instruments. This is an issue if the LAS creates and presents aliquoted tubes to an instrument and the tubes that have a different sample ID that the one the LIS downloaded.


Interface Topology

Figure 30: Interface Topology - Case 1

Case 2

The LAS intercepts communication between the LIS and on-track instruments. The LIS communicates directly with off-track instruments.

The LAS has the sole responsibility for the management of samples it creates, for example aliquoted samples. Additionally the LAS is responsible for providing a recovery/backup mode if the LIS interface goes down.

This topology allows for a mixture of ordering schemes to be used. For example the LIS-LAS interface may be broadcast download and the LAS-Instrument may be host query.


Interface Topology


Case 3

The LAS intercepts communication between the LIS and all instruments, both on-track and off-track.

Similar to Case 2, the LAS has the sole responsibility for the management of samples it creates, for example aliquoted samples. One advantage to this approach over that of Case 2 is that aliquoted samples can be run on off-track instruments. Additionally the LAS is responsible for providing a recovery/backup mode should the LIS interface goes down.

This topology allows for a mixture of ordering schemes to be used. For example the LIS-LAS interface may be broadcast download and the LAS-Instrument may be host query.


Interface Topology



Patient Safety Considerations

Section 7. Safety and PrecautionsAny safety considerations and precautions that can be controlled at the system level are included in the design of the system. Some potential risks require that the lab automation system follow a specific protocol when interacting with the system. Other potential risks relate to the lab automation system itself. The following considerations are vital to enhance the safety and reliability of Ortho Clinical Diagnostics’s systems and the automation systems to which they connect:

• Patient safety

• Operator safety

• Environmental safety

Automation vendors understand the need for strict compliance with system protocols. Lab automation system designers are strongly encouraged to consider these possible risks when designing interfaces between these products. If the system is used in a manner not specified by Ortho Clinical Diagnostics, the protection provided by the equipment may be impaired. Risks that are strictly controlled within the system and that were considered during the system's design are not shown below.


Potential Risk Potential Result Recommended Preventive Action

Contamination from the chemical cleaning agent

Contamination or degradation of sample

Refer to the Reference Guide for cleaning agents and protocol. See the onboard V-

Docs for VITROS® 4600 System or Reference Guide, J39821 on the CD-ROM.

Particulate contamination of sample on the automation track


Remove the stopper from sample tubes as close to the system as possible to maintain sample quality.

For any volatile assays, evaporation or out-gassing while the sample tube is on the automation track

Degradation of sample

Remove the stopper from sample tubes as close to system as possible to maintain sample quality.

Cross contamination from adjacent sample on the automation track


Set up automation systems to handle samples in a manner that prevents cross contamination.

Sample cross-contamination - Aspirating second fluid quantity into same tip (“double dip”) when the sample on track has been released too early and next sample is in position.

Cross-contamination of sample on track

Make sure that LAS receives a SAMPLE COMPLETE message from the system before releasing the sample. Refer to Sample Metering Handshaking on page 24.



Sample too cold after holding in refrigerated section of track for reflex testing. (Automation track supplier controls temperature)

Sample temperatureoutside system limits

Provide a means of sample temperature equilibration to room temperature after refrigeration before the sample is presented for metering at the system.

Misalignment of automation track with the system.

Sample aspirate volume error

Follow specifications for sample tube location specified in Sample Center Device Adjustments: Positioning Responsibilities on page 47.

EMI from automation track to the system via coupling.


• Ensure that automation track meets agency specifications.

• Isolate the mechanical coupling between the sample automation track and the system to address potential EMI concerns.

Over-wet sample tip or aspiration of air because the tube diameter information from automation system is incorrect.


• Use error checking communication protocol (CRC).

• Follow communications specifications in Section 2. Software Interfaces.

Sample tube breaks at automation track and the system interface.

System synchronization or timing error

• Refer to acceptable sample tube sizes for the specified in Section 4. Sample Handling.

• Design the detection of the sample tube height into the sample track.

• Detect time-out of sample metering subsystem and communicate error to LAS/LIS.

Communication error between the system and the LAS.

System synchronization/ timing error

Follow communications specifications in Section 2. Software Interfaces.

Incorrect sample presented to the system.

Aspirate from incorrect sample

Ensure the integrity of the sample ID communicated to the system and positioning of that sample.

Sample ID mis-communicated from LAS.


Verify sample ID in the SAMPLE COMPLETE message sent to LAS.

Automation track system misreads the sample tube/carrier barcode.


Use barcode verification for labels (i.e., check digit) and limit the scanner view to one sample.



Operator Considerations

Operator Considerations


Electric shock at automation track-to-system coupling.

Electrical hazards

Make sure that track is properly grounded.

Inadequate consumables (reagents, tips, etc.) on the system to complete the test.

Test not completed

• Send system resource inventory to LIS upon request.

• Verify adequate supplies by LAS via LIS. If the supplies are inadequate, have the LAS reroute the sample to another system.

STAT sample on the track is unknown to the system. (All samples on the system have priority over samples on the track.)

A STAT sample on the track may not be processed in a timely fashion

Place STAT samples on the system manually and process as locally loaded samples.

Sample tube arrives with stopper inserted in tube.

Test not executed

Remove stoppers (caps) from sample tubes to allow the system to access the tubes. Remove caps when the tubes are as close to the system as possible to ensure sample quality.

Sample Metering general error report is interpreted incorrectly by the LAS.

Test not completed

• Use error checking communication protocol (CRC).

• Use message formats specified in Section 2. Software Interfaces.

Inactive subsystem(s) on the system.

Test not completed

Have the LAS verify the system status before the sample arrives.

Software suppressed results (due to a detected error) for a STAT test.

Test not completed within expected time

• Place STAT samples on the system manually and process as locally loaded samples.

• Verify the system status and condition reports by LAS/LIS



Environmental Considerations

Environmental Considerations


Metering proboscis stuck in sample tube on track when sample is released by the automation system

Mechanical damage to sample track area and system

• Initialize sample metering subsystem by LAS if it receives a SAMPLE COMPLETE message combined with a sample metering error message from the system.

• Do not move the sample from metering position until the LAS receives a SAMPLE COMPLETE status without an error message from the system.


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Specification for Automation Interface

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